Dapa training

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Yeah, that was pretty pathetic. It's obvious the webcast was just a box that had to be checked off before they could test us, and was pretty amateurish. And did you hear the woman say the exam was "not a job-contingent test"? Interesting.
 




I also heard that it was NOT timed! hallelujah! Timed tests are ok, just not the 90 sec per question that bms does! give me the 60 minutes for the whole exam, not the 90 sec per question--that is over the top ridiculous.
 








I was in agreement with all of these comments, but then realized it was better than having to fly to some stupid place for a little training. Fly away training is ALWAYS BAD and never worth the extra time involved. At least this was only a couple hours and glean from it whatever we can of benefit. I'll gladly give them a little time at home rather than fly to New Jersey for three days. Sorry, ball up and get over it.
 








Anonymous said:
When do we get the 5 oncology binder section of the side effect module?
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Why you want to expose patients to this. BMS did not do the proper testing to satisfy the FDA. Totally arrogant. They will get what they deserve. And remember Invokana is more effective without the problems. Even if it got approved the baggage in the insert will be used by competitors to kill it. and remember managed care. Look at Onglyza and Bydureon managed care.
 




Anonymous said:
Why you want to expose patients to this. BMS did not do the proper testing to satisfy the FDA. Totally arrogant. They will get what they deserve. And remember Invokana is more effective without the problems. Even if it got approved the baggage in the insert will be used by competitors to kill it. and remember managed care. Look at Onglyza and Bydureon managed care.
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Apparently there is also problems with 2 of the studies with coronary disease that do not agree with the others. Any comments.
 




Anonymous said:
Why you want to expose patients to this. BMS did not do the proper testing to satisfy the FDA. Totally arrogant. They will get what they deserve. And remember Invokana is more effective without the problems. Even if it got approved the baggage in the insert will be used by competitors to kill it. and remember managed care. Look at Onglyza and Bydureon managed care.
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I'm not sure I'd characterize it that way. I just read the entire submission packet posted by the FDA for the Committee's review and it answers a lot of those questions, but raises others.

AZ/BMS was forced to do additional safety trials and provide further information on other data.

1) AZ/BMS evidently decided to do animal studies on the bladder cancer issue using a design/technique not favored by, or at least not the best design according to the Agency. The data from those studies was positive for Dapa in that it showed no impact on bladder tumor growth, but it didn't provide the insight the Agency wanted. Someone made a big boo-boo here, imho. If anything kills Dapa's approval, this would be it.
I think it will still be approved, but with a Warning.

2) Liver Toxicity comes down to one individual potential case related to Dapa use. All others have been adjudicated as not related to drug therapy. They are trying like hell to get it (appropriately) reclassified as something else, but it appears to still be a question mark. I figure this will show up as a precaution.

3) Breast cancer risk appears to be explained away. Expert commentary says no way to attribute it to Dapa with the current data. Agency appears ok with that.

4) Potential CV Benefit gets substantially muddied. Two new studies on at-risk patients with a history of CV disease actually trended the opposite way as the initial trials suggested. The overall statistical benefit shrunk slightly, but is still positive. Unlikely its going in the label in any way shape or form. AZ/BMS might want to reconsider actually enrolling 17,000 patients in TIMI-58 that will probably get the same kind of result that Onglyza just saw in that outcome trial.

The Agency comes right out and asks committee members to weight in on whether the CV and other benefits outweigh the potential cancer and liver issues. It should be an interesting discussion, but I think Dapa makes it through.
 




Anonymous said:
I'm not sure I'd characterize it that way. I just read the entire submission packet posted by the FDA for the Committee's review and it answers a lot of those questions, but raises others.

AZ/BMS was forced to do additional safety trials and provide further information on other data.

1) AZ/BMS evidently decided to do animal studies on the bladder cancer issue using a design/technique not favored by, or at least not the best design according to the Agency. The data from those studies was positive for Dapa in that it showed no impact on bladder tumor growth, but it didn't provide the insight the Agency wanted. Someone made a big boo-boo here, imho. If anything kills Dapa's approval, this would be it.
I think it will still be approved, but with a Warning.

2) Liver Toxicity comes down to one individual potential case related to Dapa use. All others have been adjudicated as not related to drug therapy. They are trying like hell to get it (appropriately) reclassified as something else, but it appears to still be a question mark. I figure this will show up as a precaution.

3) Breast cancer risk appears to be explained away. Expert commentary says no way to attribute it to Dapa with the current data. Agency appears ok with that.

4) Potential CV Benefit gets substantially muddied. Two new studies on at-risk patients with a history of CV disease actually trended the opposite way as the initial trials suggested. The overall statistical benefit shrunk slightly, but is still positive. Unlikely its going in the label in any way shape or form. AZ/BMS might want to reconsider actually enrolling 17,000 patients in TIMI-58 that will probably get the same kind of result that Onglyza just saw in that outcome trial.

The Agency comes right out and asks committee members to weight in on whether the CV and other benefits outweigh the potential cancer and liver issues. It should be an interesting discussion, but I think Dapa makes it through.
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No way this gets approved this time. Too many questions. Read pink sheet which gives excellent synopsis. Remember Effient and Nesina. Less problems with those drugs yet took forever to approve. Remember Invokana is better at lowering glucose and has much less baggage
 








Anonymous said:
What a useless hour. Girl just read the slides and could hear baby talking in background. Wonderful
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Why is Invokana more effective than dapa and dapa will only be able to be used in patients with GFR greater than 60 where as Invokana's cutoff is 45. Invokana has no issues with bladder cancer and and and and. We are fucked. May get approved then what. managed care
 




















Anonymous said:
No way this gets approved this time. Too many questions. Read pink sheet which gives excellent synopsis. Remember Effient and Nesina. Less problems with those drugs yet took forever to approve. Remember Invokana is better at lowering glucose and has much less baggage
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Well, I guess you and the Pink Sheet were wrong on pretty much every count. Thanks for playing. And Invokana is not 'better' at lowering A1C. As discussed by the committee, efficacy is similar. Sorry if you don't understand that.
 




Anonymous said:
Well, I guess you and the Pink Sheet were wrong on pretty much every count. Thanks for playing. And Invokana is not 'better' at lowering A1C. As discussed by the committee, efficacy is similar. Sorry if you don't understand that.
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Drug is a dog and look at the efficacy data for Invokana. It is indeed better. You will see as you train
 








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